A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Stadol Side Effects, and Drug Interactions - Butorphanol Tartrate
Stadol Side Effects, and Drug Interactions - Butorphanol Tartrate
SIDE EFFECTS
A total of 2446 patients were studied in butorphanol clinical
trials. Approximately half received STADOL Injection with the remainder
receiving STADOL NS. In nearly
all cases the type and incidence
of side effects with butorphanol
by any route were those commonly observed with opioid
analgesics.
The adverse experiences described below are based on data from short-
and long-term clinical trials
as well as postmarketing experience
in patients receiving butorphanol by any route. There has been no
attempt to correct for placebo
effect or to subtract the frequencies
reported by placebo treated
patients in controlled trials.
The most frequently reported adverse experiences across all clinical
trials with STADOL Injection and STADOL NS were somnolence
(43%), dizziness (19%), nausea
and or vomiting (13%). In
long-term trials with STADOL NS only, nasal
congestion (13%) and insomnia
(11%) were frequently reported.
The following adverse experiences were reported at a frequency
of 1% or greater in clinical
trials, and were considered to be probably related to the use of butorphanol:
Body as a Whole: asthenia/lethargy*, headache*, sensation
of heat
Cardiovascular: VASODILATION*, PALPITATIONS
Digestive: ANOREXIA*, CONSTIPATION*, dry mouth*, nausea
and/or vomiting (13%), stomach
pain
Nervous: anxiety,
confusion*, dizziness (19%),
euphoria, floating feeling, INSOMNIA (11%), nervousness, paresthesia,
somnolence (43%), TREMOR
Respiratory: BRONCHITIS, COUGH, DYSPNEA*, EPISTAXIS*, NASAL
CONGESTION (13%), NASAL IRRITATION*, PHARYNGITIS*, RHINITIS*, SINUS CONGESTION*,
SINUSITIS, UPPER RESPIRATORY INFECTION*
Skin and Appendages: sweating/ clammy*, pruritus
Special Senses: blurred vision, EAR PAIN, TINNITUS*, UNPLEASANT
TASTE* (also seen in short-term trials with STADOL NS).
(Reactions occurring with a frequency
of 3–9% are marked with an asterisk.* Reactions reported predominantly
from long- term trials with STADOL
NS are CAPITALIZED.)
The following adverse experiences were reported from postmarketing experience
or with a frequency of less
than 1% in clinical trials,
and were considered to be probably related to the use of butorphanol.
Body as a Whole: excessive drug
effect associated with transient
difficulty speaking and/or executing purposeful movements
Cardiovascular: hypotension,
syncope
Nervous: abnormal
dreams, agitation, drug
dependence, dysphoria, hallucinations, hostility, vertigo,
withdrawal symptoms
Skin and Appendages: rash/ hives
Urogenital: impaired urination
(Reactions reported only from postmarketing experience
are italicized.)
The following infrequent additional adverse experiences were reported
in a frequency of less than
1% of the patients studied in short-term STADOL NS trials and from postmarketing
experiences under circumstances where the association
between these events and butorphanol administration
is unknown. They are being listed as alerting information for the physician.
Body as a Whole: edema
Cardiovascular: chest
pain, hypertension,
tachycardia
Nervous: convulsion, delusion, depression
Respiratory: apnea, shallow breathing
(Reactions reported only from postmarketing experience
are italicized.)
Drug Abuse And Dependence
STADOL (butorphanol tartrate) Injection and STADOL NS are classified
by the Drug Enforcement Administration as Schedule IV.
Although the mixed agonist-antagonist
opioid analgesics, as a class,
have lower abuse potential
than morphine, all such drugs can be and have been reported to be abused.
Clinical Trial Experience
Probable withdrawal symptoms
were reported in <1% of patients using STADOL NS in controlled clinical
trials. However, in one study where patients with chronic
pain were treated with STADOL
NS for up to 6 months, overuse and probable withdrawal
symptoms were each reported in approximately 3% of patients. Patients
abruptly discontinuing STADOL NS after extended use or high doses were
at greatest risk for symptoms.
Postmarketing Experience
Butorphanol tartrate has
been associated with episodes of abuse
and dependence. Of the cases received, there were more reports of abuse
with the nasal spray
formulation than with the injectable
formulation.
Proper patient selection,
dose and prescribing limitations,
appropriate directions for use, and frequent monitoring are important
to minimize the risk of abuse
and dependence with butorphanol
tartrate. Special care should be exercised in administering butorphanol
to patients with a history
of drug abuse or to patients
receiving the drug on a repeated
basis for an extended period
of time.
DRUG INTERACTIONS
Concurrent use of butorphanol with central
nervous system
depressants (e.g., alcohol,
barbiturates, tranquilizers, and antihistamines) may result in increased
central nervous
system depressant
effects. When used concurrently with such drugs, the dose
of butorphanol should be the smallest effective dose and the frequency
of dosing reduced as much as possible when administered concomitantly
with drugs that potentiate
the action of opioids.
It is not known if the effects of butorphanol are altered by concomitant
medications that affect hepatic
metabolism of drugs (cimetidine,
erythromycin, theophylline, etc.), but physicians should be alert to the
possibility that a smaller initial
dose and longer intervals between
doses may be needed.
The fraction of STADOL NS
absorbed is unaffected by the concomitant administration of a nasal
vasoconstrictor (oxymetazoline),
but the rate of absorption
is decreased. Therefore, a slower onset can be anticipated if STADOL NS
is administered concomitantly with, or immediately following, a nasal
vasoconstrictor.
No information is available about the use of butorphanol concurrently
with MAO inhibitors.
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